| 2026-07-29 |
K262240 |
SSPC NXT Delivery Catheter |
DQY |
— |
— |
| 2026-07-29 |
K261766 |
CPS Locator 3D Plus Delivery Catheter |
DQY |
— |
— |
| 2026-06-05 |
K261492 |
FieldFlex Steerable Sheath |
DYB |
Class II |
Cardiovascular |
| 2026-04-07 |
K260942 |
AuST Steerable Sheath |
DYB |
Class II |
Cardiovascular |
| 2026-02-19 |
K260163 |
AuST CSP Introducer |
DYB |
Class II |
Cardiovascular |
| 2025-08-22 |
K250147 |
CPS Locator 3D Delivery Catheter |
DQY |
— |
— |
| 2025-06-27 |
K250828 |
CPS Locator 3D Plus Delivery Catheter |
DQY |
— |
— |
| 2025-06-18 |
K250492 |
FlexiGo 3D Delivery Catheter |
DQY |
— |
— |
| 2025-04-30 |
K251051 |
AuST Steerable Sheath |
DYB |
Class II |
Cardiovascular |
| 2024-12-04 |
K243180 |
SSPC NXT Delivery Catheter |
DQY |
— |
— |
| 2024-10-04 |
K242106 |
AuST Steerable Sheath |
DYB |
Class II |
Cardiovascular |
| 2024-05-02 |
K233752 |
Dragonfly Pancreaticobiliary Scope; Dragonfly Digital Controller; Dragonfly Instrument Channel Caps |
FBN |
Class II |
Gastroenterology, Urology |
| 2024-05-01 |
K240829 |
AuST Steerable Sheath |
DYB |
Class II |
Cardiovascular |
| 2023-07-31 |
K223097 |
RenaNav Ureteroscope System |
FGB |
— |
— |
| 2023-03-09 |
K230363 |
CPS Locator 3D Delivery Catheter |
DQY |
— |
— |
| 2021-11-24 |
K210009 |
Guiding Catheter |
DQY |
— |
— |